RLS Drug Trial Yields Promising Results
Astellas Pharma Inc, Tokyo, and XenoPort Inc, Santa Clara, Calif, released preliminary top-line results from a phase 2 clinical trial of ASP8825/XP13512 for treatment of moderate-to-severe primary restless legs syndrome (RLS). ASP8825/XP13512 demonstrated statistically significant improvements compared to placebo on the primary endpoint of the trial.
The primary endpoint of the phase 2 trial was the change from baseline for the International RLS rating scale score at the end of treatment. Treatment with 1,200 mg of ASP8825/XP13512 was associated with a statistically significant improvement in the primary endpoint compared to placebo. The most commonly reported adverse events were somnolence and dizziness, which were generally transient and mild to moderate in severity.
“We believe that there is a substantial unmet medical need for a medicine to treat RLS patients and are very pleased with the quality and consistency of data in this phase 2 trial showing statistically significant improvements,” says Masafumi Nogimori, president and chief executive officer of Astellas. “We look forward to meeting with the regulatory agency to discuss the development path for ASP8825/XP13512 and continuing our great partnership with XenoPort.”
“We look forward to working with Astellas to advance the development of ASP8825/XP13512 within the Astellas territory and moving closer to achieving our objective of making a new therapy available to RLS sufferers throughout the world,” says Ronald W. Barrett, PhD, chief executive officer of XenoPort
